Calibration Manager

SHL Medical is the world-leading solution provider in designing, developing, and manufacturing advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland in late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

To oversee and manage all aspects of the site calibration program including scheduling, resource management, customer satisfaction, quality, auditing, innovation, and budget. The position is a technical leader for the site, responsible for developing and motivating a team of calibration technicians across the building and processes to deliver exceptional results for manufacturing operations. He will set the overall calibration strategy for the site to ensure overall program efficiency, compliance with regulations, and implementation of best practices and innovative technologies

Main Responsibilities

• Wrote/Revise calibration procedures SOP & Work Instructions to ensure GMP compliance.
• Calibrate and repair instruments with standards traceable to NIST and FDA standards.
• Manages to completion of all calibration and instrumentation repair activities according to schedule to minimize the impact on manufacturing.
• Manages Calibration Technicians and/or Calibration contractors including technical development, setting of goals and performance expectations, and succession planning.
• Implements continuous improvement projects to increase the efficiency of the site calibration program including optimizing calibration tolerances and frequencies, implementing new calibration standards, assessing in-house vs outsourced calibrations, streamlining calibration procedures/working instruction, and performing criticality assessments.
• Conduct and perform quality management internal audits and responsible for writing/validating calibration protocols and providing technical support for calibration technicians and/or engineers.
• Make departmental decisions to assure full compliance with GMP’s and other related requirements.
• Lead calibration for all in-house accredit auditing through ISO9001, NIST, and ANAB/NAVLAB accreditations.
• Analyze technical data, commercial manuals, and schematics to diagnose malfunctioning TMDE, (Test, Measurement & Diagnostic Equipment), and identify suitable corrective action.
• Work with limited supervision to isolate, diagnose and troubleshoot equipment problems related to process equipment failures and calibrations.
• Perform equipment and instrumentation calibrations, qualifications, and troubleshooting in a pharmaceutical testing laboratory setting following cGMP and GLP practices.
• Support investigations for calibration Out of Tolerances and Quality Notifications and ensure corrective and preventive actions are implemented on time to prevent the reoccurrence of events.
• Owns the site Asset Lifecycle Management Plan for calibrated instruments and prioritizes capital investments to upgrade instrumentation
• Delivers timely resolution of all technical issues and investigations for calibration Out of Tolerances and Quality Notifications for on-site calibrated instruments and systems.
• Designs calibration strategy for new and existing instruments, defining accuracy tolerances and determining/revising calibration intervals.
• Perform all aspects of metrology activities including calibration, repair, & certification of precision electronic measuring instruments.
• Aid in audits, CAPA, LIRs.
• Evaluate CMMS historical equipment trends in support of root cause investigations.
• Create a work environment with safety as a high priority.
• Enforce all health and safety rules and regulations according to state/federal laws and company protocol
• Ability to supervise a team of calibration technicians with both technical and interpersonal skills to motivate, develop, and build morale.

Skills and Qualification

• Bachelor’s degree in engineering or a related field.
• At least 5 years of experience in a calibration/metrology management role, preferably working with injection molding equipment and machinery, automation, and/or robotics in a medical device manufacturing facility and fully automated assembly machines.
• Ability to present technical information confidently and clearly enough for a diverse audience
• Proficient with setting budgets and forecasting annual expenses
• Proficient with Computerized Maintenance Management Systems to track all plant maintenance and calibration activities
• Strong working knowledge of instrument Calibration/Metrology practices and methods, (pressure, temperature, pH, weight, time, etc.)
• Excellent interpersonal effectiveness and communication skills (written and oral) required to interface across departments and management levels
• Proficient at reading and using schematics and P&ID drawings.
• Advanced computer skills including advanced Excel functions
• Project management skills and ability to mentor team members to deliver projects
• Lean manufacturing experience and ability to coach team members on identifying lean opportunities

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

Disclaimer: This job description provides a high-level job definition. It is not intended to provide a comprehensive or exclusive list of job duties. As such, job duties and/or responsibilities within the context of this job requisition may change at the discretion of the employee’s direct supervisor.

Physical Demands:

• The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• While performing the duties of this job, the employee is regularly required to, stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach.
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required.

Work Environment:

• The work environment characteristics described here are representative of those the employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Moderate noise (i.e., business office with computers, phones, and printers, light traffic).
• Ability to work in a confined area.
• Ability to sit at a computer terminal for an extended period.

Travel or Special Requirements:

• Driving during the workday, as well as local, out-of-state, and/or international travel, may be required to perform job duties.
• Must be able to work Holidays and Weekends schedule and off hours if necessary.

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.

Please note: For this position, we do not consider applications from recruitment agencies.